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COMParative Early Treatment Effectiveness between physical therapy and usual care for low back pain (COMPETE): study protocol for a randomized controlled trial.

ABSTRACT: Low back pain is among the leading causes of medical visits and lost duty days among members of the United States Armed Forces and represents the highest 5-year risk of permanent disability in the US Army. For certain elements of care, the timing may be just as important as the type of care. The purpose of this study is to assess the impact of the timing of access to a physical therapist by patients with low back pain, by looking at outcomes and low back pain-related healthcare utilization over a 1-year period.This trial will be a two-arm pragmatic randomized clinical trial occurring at two different clinical sites in the Military Health System. We will assess outcomes and related downstream costs for patients who access physical therapy at the primary care level compared to those that receive usual care only. There will be 220 consecutive patients randomized to receive care in either group (early physical therapy or usual care only) for the first 4 weeks, and these patients will then be allowed to receive any additional care dictated by their primary care provider for the following year. The primary outcome measure is the Oswestry Disability Index. Secondary outcome measures are the Global Rating of Change, Patient Satisfaction and 1-year healthcare utilization. Follow-ups will occur at 4 weeks, 3 months and 1 year.This trial takes a pragmatic approach to delivering care by enabling a usual care environment for managing low back pain, while also allowing immediate access to physical therapy. After the initial intervention, the patient's primary provider can continue to manage the patient as he/she normally would in practice. The Military Health System Data Repository will capture all low back pain-related healthcare utilization that occurs in order to allow for a comparison between groups. Analysis from retrospective cohorts has shown improved outcomes and decreased costs for patients that received early versus late physical therapy, but this has yet to be shown in prospective trials.ClinicalTrials.Gov NCT01556581 initially on 14 March 2012.

SUBMITTER: Rhon D

PROVIDER: S-EPMC4581511 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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COMParative Early Treatment Effectiveness between physical therapy and usual care for low back pain (COMPETE): study protocol for a randomized controlled trial.

Rhon Daniel D Fritz Julie J

Trials 20150923

<h4>Background</h4>Low back pain is among the leading causes of medical visits and lost duty days among members of the United States Armed Forces and represents the highest 5-year risk of permanent disability in the US Army. For certain elements of care, the timing may be just as important as the type of care. The purpose of this study is to assess the impact of the timing of access to a physical therapist by patients with low back pain, by looking at outcomes and low back pain-related healthcar ...[more]

PMID: 26399603

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Project description:ImportanceIt is critically important to evaluate the effect of nonpharmacological treatments on low back pain and associated disability.ObjectiveTo determine whether the addition of chiropractic care to usual medical care results in better pain relief and pain-related function when compared with usual medical care alone.Design, setting, and participantsA 3-site pragmatic comparative effectiveness clinical trial using adaptive allocation was conducted from September 28, 2012, to February 13, 2016, at 2 large military medical centers in major metropolitan areas and 1 smaller hospital at a military training site. Eligible participants were active-duty US service members aged 18 to 50 years with low back pain from a musculoskeletal source.InterventionsThe intervention period was 6 weeks. Usual medical care included self-care, medications, physical therapy, and pain clinic referral. Chiropractic care included spinal manipulative therapy in the low back and adjacent regions and additional therapeutic procedures such as rehabilitative exercise, cryotherapy, superficial heat, and other manual therapies.Main outcomes and measuresCoprimary outcomes were low back pain intensity (Numerical Rating Scale; scores ranging from 0 [no low back pain] to 10 [worst possible low back pain]) and disability (Roland Morris Disability Questionnaire; scores ranging from 0-24, with higher scores indicating greater disability) at 6 weeks. Secondary outcomes included perceived improvement, satisfaction (Numerical Rating Scale; scores ranging from 0 [not at all satisfied] to 10 [extremely satisfied]), and medication use. The coprimary outcomes were modeled with linear mixed-effects regression over baseline and weeks 2, 4, 6, and 12.ResultsOf the 806 screened patients who were recruited through either clinician referrals or self-referrals, 750 were enrolled (250 at each site). The mean (SD) participant age was 30.9 (8.7) years, 175 participants (23.3%) were female, and 243 participants (32.4%) were nonwhite. Statistically significant site × time × group interactions were found in all models. Adjusted mean differences in scores at week 6 were statistically significant in favor of usual medical care plus chiropractic care compared with usual medical care alone overall for low back pain intensity (mean difference, -1.1; 95% CI, -1.4 to -0.7), disability (mean difference, -2.2; 95% CI, -3.1 to -1.2), and satisfaction (mean difference, 2.5; 95% CI, 2.1 to 2.8) as well as at each site. Adjusted odd ratios at week 6 were also statistically significant in favor of usual medical care plus chiropractic care overall for perceived improvement (odds ratio = 0.18; 95% CI, 0.13-0.25) and self-reported pain medication use (odds ratio = 0.73; 95% CI, 0.54-0.97). No serious related adverse events were reported.Conclusions and relevanceChiropractic care, when added to usual medical care, resulted in moderate short-term improvements in low back pain intensity and disability in active-duty military personnel. This trial provides additional support for the inclusion of chiropractic care as a component of multidisciplinary health care for low back pain, as currently recommended in existing guidelines. However, study limitations illustrate that further research is needed to understand longer-term outcomes as well as how patient heterogeneity and intervention variations affect patient responses to chiropractic care.Trial registrationClinicalTrials.gov Identifier: NCT01692275.

Project description:BACKGROUND:Chiropractic care is a popular alternative for back and neck pain, with efficacy comparable to usual care in randomized trials. However, the effectiveness of chiropractic care as delivered through conventional care settings remains largely unexplored. OBJECTIVE:To evaluate the comparative effectiveness of usual care with or without chiropractic care for patients with chronic recurrent musculoskeletal back and neck pain. STUDY DESIGN:Prospective cohort study using propensity score-matched controls. PARTICIPANTS:Using retrospective electronic health record data, we developed a propensity score model predicting likelihood of chiropractic referral. Eligible patients with back or neck pain were then contacted upon referral for chiropractic care and enrolled in a prospective study. For each referred patient, two propensity score-matched non-referred patients were contacted and enrolled. We followed the participants prospectively for 6 months. MAIN MEASURES:Main outcomes included pain severity, interference, and symptom bothersomeness. Secondary outcomes included expenditures for pain-related health care. KEY RESULTS:Both groups' (N = 70 referred, 139 non-referred) pain scores improved significantly over the first 3 months, with less change between months 3 and 6. No significant between-group difference was observed. (severity - 0.10 (95% CI - 0.30, 0.10), interference - 0.07 (- 0.31, 0.16), bothersomeness - 0.1 (- 0.39, 0.19)). After controlling for variances in baseline costs, total costs during the 6-month post-enrollment follow-up were significantly higher on average in the non-referred versus referred group ($1996 [SD = 3874] vs $1086 [SD = 1212], p = .034). Adjusting for differences in age, gender, and Charlson comorbidity index attenuated this finding, which was no longer statistically significant (p = .072). CONCLUSIONS:We found no statistically significant difference between the two groups in either patient-reported or economic outcomes. As clinical outcomes were similar, and the provision of chiropractic care did not increase costs, making chiropractic services available provided an additional viable option for patients who prefer this type of care, at no additional expense.

Project description:IntroductionChronic low back pain disorders (CLBDs) present a substantial societal burden; however, optimal treatment remains debated. To date, pairwise and network meta-analyses have evaluated individual treatment modes, yet a comparison of a wide range of common treatments is required to evaluate their relative effectiveness. Using network meta-analysis, we aim to evaluate the effectiveness of treatments (acupuncture, education or advice, electrophysical agents, exercise, manual therapies/manipulation, massage, the McKenzie method, pharmacotherapy, psychological therapies, surgery, epidural injections, percutaneous treatments, traction, physical therapy, multidisciplinary pain management, placebo, 'usual care' and/or no treatment) on pain intensity, disability and/or mental health in patients with CLBDs.Methods and analysisSix electronic databases and reference lists of 285 prior systematic reviews were searched. Eligible studies will be randomised controlled/clinical trials (including cross-over and cluster designs) that examine individual treatments or treatment combinations in adult patients with CLBDs. Studies must be published in English, German or Chinese as a full-journal publication in a peer-reviewed journal. A narrative approach will be used to synthesise and report qualitative and quantitative data, and, where feasible, network meta-analyses will be performed. Reporting of the review will be informed by Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidance, including the network meta-analysis extension (PRISMA-NMA). The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach for network meta-analysis will be implemented for assessing the quality of the findings.Ethics and disseminationEthical approval is not required for this systematic review of the published data. Findings will be disseminated via peer-reviewed publication.Prospero registration numberPROSPERO registration number CRD42020182039.

Project description:BACKGROUND:Acupuncture is a popular complementary and alternative treatment for chronic back pain. Recent European trials suggest similar short-term benefits from real and sham acupuncture needling. This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain. METHODS:A total of 638 adults with chronic mechanical low back pain were randomized to individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care. Ten treatments were provided over 7 weeks by experienced acupuncturists. The primary outcomes were back-related dysfunction (Roland-Morris Disability Questionnaire score; range, 0-23) and symptom bothersomeness (0-10 scale). Outcomes were assessed at baseline and after 8, 26, and 52 weeks. RESULTS:At 8 weeks, mean dysfunction scores for the individualized, standardized, and simulated acupuncture groups improved by 4.4, 4.5, and 4.4 points, respectively, compared with 2.1 points for those receiving usual care (P < .001). Participants receiving real or simulated acupuncture were more likely than those receiving usual care to experience clinically meaningful improvements on the dysfunction scale (60% vs 39%; P < .001). Symptoms improved by 1.6 to 1.9 points in the treatment groups compared with 0.7 points in the usual care group (P < .001). After 1 year, participants in the treatment groups were more likely than those receiving usual care to experience clinically meaningful improvements in dysfunction (59% to 65% vs 50%, respectively; P = .02) but not in symptoms (P > .05). CONCLUSIONS:Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits. These findings raise questions about acupuncture's purported mechanisms of action. It remains unclear whether acupuncture or our simulated method of acupuncture provide physiologically important stimulation or represent placebo or nonspecific effects.

Project description:Low back pain (LBP) is a prevalent condition and a socioeconomic problem in many countries. Due to its recurrent nature, the prevention of further episodes (secondary prevention), seems logical. Furthermore, when the condition is persistent, the minimization of symptoms and prevention of deterioration (tertiary prevention), is equally important. Research has largely focused on treatment methods for symptomatic episodes, and little is known about preventive treatment strategies.This study protocol describes a randomized controlled clinical trial in a multicenter setting investigating the effect and cost-effectiveness of preventive manual care (chiropractic maintenance care) in a population of patients with recurrent or persistent LBP.Four hundred consecutive study subjects with recurrent or persistent LBP will be recruited from chiropractic clinics in Sweden. The primary outcome is the number of days with bothersome pain over 12 months. Secondary measures are self-rated health (EQ-5D), function (the Roland Morris Disability Questionnaire), psychological profile (the Multidimensional Pain Inventory), pain intensity (the Numeric Rating Scale), and work absence.The primary utility measure of the study is quality-adjusted life years and will be calculated using the EQ-5D questionnaire. Direct medical costs as well as indirect costs will be considered.Subjects are randomly allocated into two treatment arms: 1) Symptom-guided treatment (patient controlled), receiving care when patients feel a need. 2) Preventive treatment (clinician controlled), receiving care on a regular basis. Eligibility screening takes place in two phases: first, when assessing the primary inclusion/exclusion criteria, and then to only include fast responders, i.e., subjects who respond well to initial treatment. Data are collected at baseline and at follow-up as well as weekly, using SMS text messages.This study investigates a manual strategy (chiropractic maintenance care) for recurrent and persistent LBP and aims to answer questions regarding the effect and cost-effectiveness of this preventive approach. Strict inclusion criteria should ensure a suitable target group and the use of frequent data collection should provide an accurate outcome measurement. The study utilizes normal clinical procedures, which should aid the transferability of the results.Clinical trials.gov; NCT01539863, February 22, 2012. The first patient was randomized into the study on April 13th 2012.

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COMParative Early Treatment Effectiveness between physical therapy and usual care for low back pain (COMPETE): study protocol for a randomized controlled trial.

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COMParative Early Treatment Effectiveness between physical therapy and usual care for low back pain (COMPETE): study protocol for a randomized controlled trial.

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